In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on the totality of the available data and analyses.

In the search for a DES able to improve the currently poor performance of PCI in DM patients when compared to non-DM patients, Cre8™ EVO (Amphilimus™-Eluting Stent – AES) resulted superior to Onyx™ (Zotarolimus-Eluting Stent – ZES) in the independent SUGAR randomized trial with regard to Target Lesion Failure at one year (TLF 7.2% Cre8™ EVO vs. TLF 10.9% Resolute Onyx™; p superiority = 0.030). With these results, which confirm the clinical outcomes seen in many other sponsored and independent studies, Cre8™ EVO raises the bar of DES performance in DM patients.

Cre8™ EVO, the latest evolution of Alvimedica polymer-free DES family, embeds many unique technologies. Specifically, the Abluminal Reservoir Technology (the only polymer-free technology able to precisely control abluminal drug elution) and Amphilimus™ formulation (a combination of Sirolimus with Fatty Acid) allow for higher drug concentration inside VSMCs to increase DES efficacy in DM patients.

“SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes, and also the first to include a broad population of patients with diabetes,” said Rafael Romaguera, M.D., Hospital de Bellvitge, Barcelona, Spain. “In patients with diabetes mellitus undergoing percutaneous revascularization, the study found that Amphilimus™-eluting stents were superior to Onyx™-zotarolimus-eluting stents with a 35% reduction in the risk of target lesion failure at one year.”

The SUGAR randomized trial was funded by the Spanish Society of Cardiology and the Spanish Heart Foundation.